补肾活血方联合常规西药治疗类风湿关节炎的疗效及安全性分析

发布时间：2018-06-12 03:06

本文选题：类风湿关节炎 + 痹证　；参考：《湖北中医药大学》2015年硕士论文

【摘要】：研究目的:类风湿关节炎是临床常见的系统性、自身免疫性疾病,其发病率、致残率高,严重影响患者的生活质量,患者一般预后较差。常规西药治疗或仅能改善疼痛症状,或起效时间较长,不良反应较多。导师根据多年临床经验,使用补肾活血方联合常规西药甲氨喋呤和来氟米特治疗肝肾亏虚、瘀血痹阻型类风湿关节炎,获得很好疗效,故设计本实验,通过临床疗效评价、症状体征观察、实验室检查结果,评价其治疗的临床疗效及安全性以更好地指导临床。研究方法:本研究收集符合西医类风湿关节炎诊断,且中医辩证属痹证肝肾亏虚、瘀血痹阻证型的患者64例。根据随机对照原则,将64例类风湿关节炎患者随机分为对照组32人、治疗组32人。经统计学分析,两组患者在性别比例、年龄、病程和关节功能分级等方面无显著性差异,具有可比性。对照组给予甲氨蝶呤联合来氟米特,治疗组在对照组基础上给予中药补肾活血方汤剂,临床观察8周。每2周记录患者临床疗效和与类风湿关节炎相关的症状体征,不能耐受的不良反应者将退出本次实验。治疗8周后复查心电图、肝肾功能和三大常规,以判断其安全性。最后统计两组患者治疗前后临床疗效、症状体征和实验室指标的差异。研究结果:1、两组患者综合疗效比较,治疗组治疗后达ACR20、ACR50患者数目明显多于对照组;治疗组临床显效率也明显高于对照组。2、在改善晨僵症状方面,治疗组与对照组比较,不仅起效时间明显缩短,而且治疗8周后晨僵时间明显缩短。治疗2周后,治疗组患者肿胀关节数较治疗前明显减少,治疗6周后患者肿胀关节数较对照组明显减少。治疗6周后,治疗组患者压痛关节数较对照组明显减少。治疗8周后,治疗组患者关节功能障碍指数较对照组明显好转。DAS28评分比较,治疗8周后,治疗组患者关节功能障碍指数较对照组明显降低。治疗4周后,治疗组患者双手平均握力较单纯西药组明显升高。疼痛10cm水平视力评分比较,治疗4周后,治疗组患者疼痛程度较治疗前明显减轻,其起效时间较对照组提前2周。健康评估积分比较,治疗4周后,治疗组患者总体健康状况较治疗前明显好转,其起效时间较对照组提前2周;治疗8周后患者健康状况较对照组明显好转。3、治疗8周后,治疗组患者急性期反应物、类风湿因子及炎症因子水平较对照组明显降低。8周治疗后,治疗组与对照组免疫球蛋白水平均明显降低,两者之间统计学差异不明显。4、中药补肾活血方不增加常规西药肝肾功能损伤、骨髓造血功能异常等副作用出现的概率。结论:中药补肾活血方联合常规西药治疗较常规西药组比较,虽然不能完全改善实验室指标,但可显著改善患者临床症状体征、生活质量,提高综合显效率,而不增加不良反应及副作用出现的概率,广泛适用于肝肾亏虚、瘀血痹阻型类风湿关节炎患者。
[Abstract]:Research objective: rheumatoid arthritis is a common systematic, autoimmune disease, its incidence and disability rate are high, the patient's quality of life is seriously affected, the patient's general prognosis is poor. Routine western medicine treatment or only can improve the pain symptoms, or the onset time is longer, and no good reaction is more. The tutor uses tonifying kidney according to years of clinical experience. The blood side combined with the conventional western medicine methotrexate and leflunomide to treat the deficiency of the liver and kidney and the stagnation of blood stasis type rheumatoid arthritis, it has got a good effect. Therefore, this experiment is designed by the clinical efficacy evaluation, the observation of symptoms and signs, the results of laboratory examination, the evaluation of the clinical efficacy and safety of the treatment to better guide the clinical. In order to collect 64 cases of rheumatoid arthritis in the diagnosis of Western medicine, and the TCM dialectical belongs to the deficiency of the liver and kidney of arthralgia syndrome and blood stasis syndrome type, according to the random control principle, 64 cases of rheumatoid arthritis were randomly divided into 32 people in the control group and 32 in the treatment group. By statistical analysis, the two groups were in the sex ratio, age, course of disease and the classification of joint function. The control group was given the combination of methotrexate and leflunomide in the control group, and the treatment group was given the decoction of invigorating kidney and activating blood for 8 weeks on the basis of the control group. The clinical efficacy and symptoms related to rheumatoid arthritis were recorded every 2 weeks. The patients who were not able to tolerate the adverse reactions would be withdrawn from this experiment. After 8 weeks of treatment, reexamination of electrocardiogram, liver and kidney function and three general routine to judge its safety. Finally, the difference between the clinical curative effect, symptoms and signs and laboratory indexes of the two groups before and after treatment was statistically analyzed. The results were as follows: 1, two groups were compared, the treatment group was ACR20, the number of ACR50 patients was obviously more than that of the control group; the clinical efficacy of the treatment group was markedly effective. The rate of the treatment group was significantly higher than that of the control group.2. In the improvement of the symptoms of morning stiffness, the treatment group was significantly shorter than the control group, and the time of morning stiffness shortened obviously after 8 weeks of treatment. After 2 weeks of treatment, the number of swelling joints in the treatment group was significantly lower than that before the treatment. The number of swelling joints in the patients was significantly reduced after 6 weeks of treatment. 6 weeks after treatment, the number of swelling joints was significantly reduced. After 8 weeks, the index of joint dysfunction index of the treatment group was significantly better than that of the control group. After 8 weeks of treatment, the joint dysfunction index of the patients in the treatment group was significantly lower than that of the control group. After 4 weeks of treatment, the average grip strength of the two hands in the treatment group was more than that of the simple western medicine group. After 4 weeks of treatment, the pain degree of the treatment group was significantly lower than that before the treatment, and the onset time of the treatment group was 2 weeks earlier than that of the control group. After 4 weeks of health assessment, the overall health status of the patients in the treatment group was significantly better than before the treatment. The onset time of the treatment group was 2 weeks ahead of the control group, and the treatment time was 2 weeks ahead of the control group, and the treatment group was treated for 8 weeks. After 8 weeks of treatment, the level of acute phase reactant, rheumatoid factor and inflammatory factor in the treatment group were significantly lower than that of the control group after 8 weeks of treatment, and the level of immunoglobulin in the treatment group and the control group decreased significantly after 8 weeks of treatment. The difference of the total immunoglobulin between the two groups was not obvious, and the traditional Chinese medicine for invigorating kidney and promoting blood circulation did not increase. Compared with conventional western medicine, the combination of traditional Chinese medicine and conventional western medicine can not completely improve the laboratory index, but it can significantly improve the clinical symptoms and signs, quality of life, improve the comprehensive efficiency, without increasing adverse reaction. The probability of occurrence of side effects should be widely applied to patients with rheumatoid arthritis of liver and kidney deficiency and stagnation of blood stasis.
【学位授予单位】：湖北中医药大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R593.22

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